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Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT04232319
Recruitment Status : Withdrawn (Due to COVID this study was never started.)
First Posted : January 18, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Danielle Mockensturm, University of Toledo Health Science Campus

Study Description
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Brief Summary:
The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.

Condition or disease Intervention/treatment Phase
Breast Cancer Sleep Hygiene Behavioral: Sleep Hygiene Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sleep Hygiene Training
The intervention will be delivered online by an occupational therapist. The intervention consists of 3 weekly sessions; each session will be 30-45 minutes long. The focus of the intervention is to teach breast cancer survivors sleep hygiene strategies to improve their sleep.
 Behavioral: Sleep Hygiene Training

The intervention will last approximately 45 minutes, and will be provided once/week for 3 weeks. The intervention is delivered "live" using web-cameras (e.g., Microsoft Zoom).

Registered and licensed occupational therapists will deliver the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge regarding sleep hygiene strategies and examples on how to apply these strategies to improve sleep quality.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Sleep Quality (Pittsburgh Sleep Quality Index) [ Time Frame: Baseline to 7 weeks ]
    Measures the quality of sleep


Secondary Outcome Measures :
  1. Change in Ecological Momentary Assessment of Sleep Quality [ Time Frame: Baseline to 7 weeks ]
    Ecological Momentary Assessments via Smartphone App

  2. Change in Actigraphy-based measure of Sleep [ Time Frame: Baseline to 7 weeks ]
    Actigraphy-based measure of Sleep

  3. Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index) [ Time Frame: Baseline to 7 weeks ]
    Measure individual's knowledge of Sleep Hygiene Strategies

  4. Change in Ecological Momentary Assessment of Sleep Quantity [ Time Frame: Baseline to 7 weeks ]
    Ecological Momentary Assessments via Smartphone App


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy,
  2. at least 18 years of age,
  3. women
  4. score > 5 on the Pittsburgh Sleep Quality Index
  5. Participant has a smartphone that operates on the Android or Apple platform
  6. Participant is able to use the Ecological Momentary Assessment application in the morning
  7. functional English fluency and literacy

Exclusion Criteria:

  1. self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment.
  2. Currently taking a pharmacological sleep aide
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232319


Locations
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United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Ketki D Raina, PhD, OTR/L The University of Toledo
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Danielle Mockensturm, Associate Professor, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT04232319    
Other Study ID Numbers: UT BCS Sleep Study
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danielle Mockensturm, University of Toledo Health Science Campus:
Breast cancer, sleep, intervention
Sleep
Intervention
Self-management
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases